Wednesday, 24 September 2025

Medical Devices

Galaxy Therapeutics Opens New 9,200 Sq. Ft. Facility to Support Global Scale-Up of Brain Aneurysm Solutions

Equipped with ISO Class 7 cleanrooms and expanded R&D capacity, the new site accelerates Galaxy’s path to commercial readiness and global distribution of its breakthrough neurovascular technologies. ...

ClariMed Achieves ISO 13485:2016 Certification, Strengthening Global Medical Device Development Capabilities

Milestone underscores ClariMed’s commitment to quality excellence and reinforces its position as a trusted partner in navigating complex global regulatory landscapes ...

Quasar Medical Establishes Global Headquarters in Singapore to Drive MedTech Innovation and Global Growth

Strategic relocation from Hong Kong strengthens ties to Asia’s thriving MedTech ecosystem, enhances collaboration with global partners, and supports ambitious expansion plans ...

Johnson & Johnson MedTech Launches VIRTUGUIDE™ System to Transform Bunion Surgery with AI Precision

AI-powered, patient-matched solution aims to simplify Lapidus procedures and enhance surgical outcomes...

How the FDA’s 510(k) Pathway and Risk-Based Oversight Are Shaping the Future of Medical Device Regulation

By aligning regulatory rigour with technological complexity, the FDA safeguards public health while accelerating access to life-changing medical innovations through adaptive pathways and total lifecycle vigilance...

Surgical Safety Technologies Introduces AI-Powered Kinematic Analysis in OR Black Box

First camera-agnostic motion tracking solution for laparoscopic surgery delivers real-time insight into surgical technique and proficiency across all devices and operating rooms ...

Stryker’s Inari Division Debuts InThrill Thrombectomy System

First and only purpose-built solution delivering rapid and complete luminal clot removal in small vessel and arteriovenous access cases...

Siemens Healthineers Leads the Way in Laboratory Sustainability with ACT Ecolabel Certification for Over 150 Diagnostic Reagents

First in the industry to achieve dual certification for both reagents and analysers within its Atellica portfolio...

Aptitude Medical Secures $9M BARDA Partnership to Advance Rapid Filovirus Diagnostic for Ebola and Marburg Detection

New Metrix Filovirus Panel to deliver 30-minute, lab-quality results from blood samples in remote and point-of-care settings—marking a pivotal step in global outbreak preparedness. ...

Stereotaxis Secures FDA Clearance for MAGiC Sweep Catheter

New magnetic ablation catheter designed to enhance precision and reach in robotic electrophysiology procedures across the U.S....